Catheter assembly with seal member

ABSTRACT

A catheter assembly includes a catheter hub defining an interior cavity and a catheter tube extending distally thereof. A rigid actuator extends proximally in the interior cavity and supports a seal member thereon. The seal member includes a central membrane, a distal portion, and a proximal portion. An hourglass shaped actuator cavity is formed in the distal portion and receives a barbed end of the actuator. The outer surface of the seal member is in partial circumferential engagement with the catheter hub to define an air path that allows fluid communication between areas of the interior cavity distal and proximal of the seal member. A punch tool is provided to form a tri-slit in the membrane of the seal member.

TECHNICAL FIELD

The present invention relates to over-the-needle catheters such asperipheral intravascular catheters or PIVC's and, more particularly, toa catheter assembly used with such catheters having a seal disposed in ahub thereof for enhanced blood control.

BACKGROUND

By way of background, conventional PIVC's include a catheter assembly,typically having a catheter hub and a catheter tube extending distallythereof, and a needle assembly mounted together in an over-the-needlefashion. The needle assembly typically includes a needle hub or supportand a needle cannula extending distally thereof and, in a ready positionof the PIVC, extending through the catheter tube to expose a sharp tipthereof distal of the tube and used to penetrate tissue for insertion ofthe catheter tube within the vascular system of a patient. Once thecatheter tube is disposed within the vasculature, the needle cannula iswithdrawn proximally from the catheter assembly and the catheterassembly remains in fluid communication with the vasculature. The PIVCmay also include a protector to enclose at least the tip of the needlecannula, if not the entire cannula, after use. A PIVC with a protectormay be referred to as a safety catheter.

The catheter hub typically has an open proximal end adapted to receive amale luer taper into the interior cavity of the catheter to establish afluid connection between the patient's vasculature and the luer taper.The proximal end may also be provided with external ears or the like tosecure the luer taper in the catheter hub, such as when the luer taperis coupled with a male luer lock collar or nut to form part of a maleluer lock such as of a connector of an administration set or the end ofa syringe, or the like. Under normal conditions, after withdrawal of theneedle cannula and before a luer taper is inserted into the catheterhub, blood immediately starts flowing through the catheter tube and intothe interior cavity of the catheter hub. In typical catheter hubdesigns, the proximal end of the catheter hub is in open communicationwith the catheter tube through the interior cavity such that, if notattended to in a timely manner, blood can flow into the catheter hub andspill into the surrounding environment. To limit blood flow into thecatheter hub, medical personnel typically apply digital pressure nearthe insertion site to occlude blood flow into the catheter tube. Anadministration set or a syringe is then coupled to the catheter assemblyfor introducing fluids into, and/or withdrawing blood from, the patient.

Various designs of catheter assemblies have been proposed forcontrolling or limiting blood flow by inclusion of a hemostasis sealwithin the interior cavity or at the proximal end opening of thecatheter hub, to block fluid flow between the proximal end of thecatheter hub and the catheter tube. In these designs, the hemostasisseal provides for passage of the needle cannula therethrough in theready position of the PIVC, but seals against the flow of blood to orout of the proximal end of the catheter hub upon proximal withdrawal ofthe needle cannula. The hemostasis seal is adapted to be opened byinsertion of a luer taper into the catheter hub to allow flow of fluidbetween the luer taper and the catheter tube.

While various designs of catheter assemblies with hemostasis seals havebeen proposed, none seems to have garnered commercial acceptance. Thus,improvements are considered necessary in order to address drawbacks ofexisting proposals.

SUMMARY

The present invention provides catheter assemblies with improvedhemostasis seal arrangements which are aimed at addressing drawbacks ofpreviously proposed catheter assembly designs. To that end, and inaccordance with one feature of the present invention, a rigid actuatorextends proximally in the interior cavity from the catheter hub distalend to a free end having an enlarged proximal flange. The enlargedproximal flange may advantageously define a barb. In accordance with afurther feature of the present invention, a seal member is disposed inthe interior cavity of the catheter hub including a membrane and adistal portion extending distally from the membrane to a sealing outletbore with the distal portion having an actuator cavity formed betweenthe membrane and the sealing outlet bore so as to receive the free endof the actuator therein through the sealing outlet bore. The actuatorcavity may advantageously have a narrowed portion that defines anhourglass shape thereto such that with the actuator extending throughthe sealing outlet bore into the actuator cavity, a surface of theproximal flange engages against the narrowed portion of the actuatorcavity. The foregoing features provide a reliable seal between the sealmember and the actuator while also providing a reliable hold of the sealmember to the actuator.

The seal member advantageously includes a proximal portion, such as acylinder, extending proximally from the membrane to a proximal enddefining an impact surface against which a free or distal end of a maleluer taper impacts upon insertion into the catheter hub interior cavityto thereby cause the seal member to slide axially along the actuator.The membrane is eventually forced open as the free end of the actuatorpasses through the membrane, which may advantageously be slit tofacilitate the opening of the membrane. The seal member isadvantageously a unitary member.

In accordance with another feature of the present invention, theactuator for the catheter assembly may include an eyelet portion adaptedto help secure the catheter tube to the catheter hub, such that theactuator is an integral part of the eyelet. To that end, the actuatormay include a main shaft having a first cross dimension, an eyeletportion at one end thereof having an eyelet shaft of a second crossdimension, with the barb at an opposite end thereof having a third crossdimension. The third cross dimension is larger than the first and secondcross dimensions, with the second cross dimension being equal to orsmaller than the first cross dimension and advantageously being sized inrelation to the gauge of the needle cannula to be used therewith. Theactuator thus provides the dual functionality of securement of thecatheter tube to the catheter hub and opening of the seal member asdesired.

In accordance with a yet further feature of the present invention, wherethe needle cannula gauge is small, such as 16 or 18 gauge wherein theneedle cannula diameter is quite large, the cross dimension of theeyelet shaft may be nearly the same size or slightly smaller than thecross dimension of the actuator main shaft. The actuator isadvantageously provided with a surface feature in the form of a radiallyoutwardly extending annular rib to enhance securement of the actuator tothe catheter hub. The annular rib may be at the junction of the main andeyelet shafts. For larger gauge needle cannula, such as 20, 22, 24,and/or 26 gauges wherein the needle cannula diameter is relativelysmall, the eyelet shaft cross dimension may be substantially smallerthan the main shaft cross dimension. If desired, the actuator may beprovided with a surface feature to enhance securement of the actuator tothe catheter hub. The surface feature may be an annular rib, or may beone or more dimples or one or more axial or annular grooves in the mainshaft adjacent the eyelet shaft.

The seal member may be supported on the actuator with an outer surfaceof the seal member in partial circumferential engagement with thecatheter hub inner surface or wall such that an air path is maintainedbetween areas of the interior cavity both distal and proximal of theseal member. The seal member is thus held against undue sideways orsimilar movement or tilting, while allowing escape of air or other fluidto facilitate movement of the seal member sliding axially along theactuator. The air path or at least a portion thereof which serves tolimit the circumferential engagement to a partial circumferentialengagement, may advantageously be defined at least in part by an axialchannel or groove in the outer surface of the seal member, wherein theseal member is not in engagement with the inner wall of the catheter hubin the area of the groove. The aspects of the seal member proximal anddistal the area of the partial circumferential engagement may be sizedwith a cross dimension smaller than the cross dimension of theconfronting areas of the catheter hub so as to form annular gapstherebetween which may also define part of the air path.

The catheter assembly may be configured to be used with a needle cannulaand a nose that projects into the interior cavity of the catheter hub.The nose advantageously has a standard luer taper proximal portion toengage with the catheter hub inner wall adjacent the proximal opening ofthe catheter hub and a distal aspect sized smaller than the standardluer portion so as to project into the proximal cylindrical portion ofthe seal member with a distal end of the nose being adjacent themembrane of the seal member. The membrane may have a slit therethroughthat defines slit flaps. The distal end of the nose may advantageouslyinclude a recessed bore that overlies the slit in the membrane. The boreis configured to receive the slit flaps during withdrawal of the needlecannula from the catheter hub.

In a further aspect of the present invention, the seal member may bedisposed in the catheter hub such that the distal end of the seal membersupporting the sealing outlet bore is spaced a first distance from thedistal end of the catheter hub and the impact end of the seal member isspaced a second distance from the proximal end of the catheter hub, withthe seal member being axially shifted, such as by the male luer taperinserted into the catheter hub, a third distance to force the membraneover the free end of the actuator to open the seal member.Advantageously, the third distance is less than the first distance suchthat the seal member is not axially compressed after being axiallyshifted the third distance to open the seal membrane. In any event, theproximal portion of the seal member is such that it is not axiallycompressed after the sealing member has been moved to the opencondition. Further advantageously, the first and second distances areeach substantially larger than the axial thickness of the seal membermembrane.

The slit of the membrane, where provided, is advantageously a tri-slitso as to form a Y-shape when seen in plan view. In accordance with a yetfurther aspect of the present invention, a punch tool for forming atri-slit in the membrane of the seal member includes a three-sidedpyramid having a base at one end with three corners and a pointed tip atan opposed end, and a shaft extending from the base and having threestraight, sharpened edges and generally planar lands between respectivepairs of edges, with each of the edges being generally axially alignedwith a respective one of the three corners of the base. An associatedmethod includes inserting the seal member in a bore of a fixture,inserting the punch tool into the fixture to engage the membrane, andcontinuing to insert the punch tool into the fixture to push at least aportion of the pyramid of the punch tool through the membrane.

By virtue of the foregoing, individually and in combination, there areprovided catheter assemblies with improved hemostasis seal arrangementswhich are aimed at addressing drawbacks of previously proposed catheterassembly designs. These and other objects and advantages of the presentinvention shall be made apparent from the accompanying drawings anddescription thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the invention and,together with the general description given above and the detaileddescription of the embodiments given below, serve to explain theprinciples of the invention.

FIG. 1 is a cross-sectional view of one embodiment of a catheterassembly having an actuator and seal member in accordance with variousfeatures of the present invention;

FIG. 2 is a partial, cross-sectional view of a PIVC including thecatheter assembly of FIG. 1 and being in a ready position for purposesof explaining various features of the present invention;

FIG. 3 is a perspective view of the actuator of FIGS. 1 and 2;

FIGS. 3A-3C are partial, perspective views showing alternativeembodiments of the actuator of FIGS. 1 and 2 for purposes of explaininga yet further feature of the present invention;

FIG. 4 is a partial, perspective view of an alternate embodiment of anactuator for the catheter assembly of FIGS. 1 and 2;

FIG. 4A is a cross-sectional view taken along line 4A-4A of FIG. 4;

FIG. 5 is a perspective view of the seal member of FIGS. 1 and 2;

FIG. 6 is a cross-sectional view of the seal member shown in FIG. 5taken generally along line 6-6 of FIG. 5;

FIG. 7 is a cross-sectional view of the seal member shown in FIG. 5taken generally along line 7-7 of FIG. 5;

FIG. 8 is a view similar to FIG. 2, but showing the needle cannula beingwithdrawn proximally for explaining a feature of the present invention;

FIG. 9 is a partial, cross-sectional view of the catheter assembly ofFIG. 1 as the seal member is being actuated to slide axially along theactuator by insertion of a male luer taper into the catheter hub;

FIG. 10 is a partial, cross-sectional view of the catheter assembly ofFIG. 1 after the seal member has been slid axially over the free end ofthe actuator to be fully opened by insertion of the male luer taper intothe catheter hub;

FIG. 11 is a view showing the seal member of FIG. 1 and a fixture incross section, and a punch tool for use therewith for forming a tri-slitin the membrane of the seal member; and

FIG. 12 is a cross-sectional view of the end of the punch tool shown inFIG. 11 taken generally along line 12-12 of FIG. 11.

DETAILED DESCRIPTION

In reference to FIG. 1, a catheter assembly 10 in accordance withvarious features of the present invention includes a catheter hub 12, acatheter tube 14 secured to and extending distally of the catheter hub12, an actuator 16 secured to the catheter hub 12 and extending axiallytherewithin, and a seal member 18 disposed in the catheter hub 12 andmovably supported on the actuator 16. The seal member 18 is axiallyshiftable relative to the actuator 16, such as by sliding axiallytherealong, between a closed or sealed position shown in FIG. 1 and anopened or actuated position (shown, for example, in FIG. 10). In theclosed position, the catheter hub 12 is substantially sealed off fromthe catheter tube 14 such that blood flow into the catheter hub 12 isrestricted. In the opened position, however, and as will be discussed inmore detail below, the seal member 18 is pushed over the actuator 16such that the catheter hub 12 and catheter tube 14 are in open fluidcommunication.

The catheter hub 12 includes a proximal end 20 with an unobstructedopening 21, a distal end 22, and an interior cavity 24 extendingtherebetween and defined by an inner surface or wall 25. The interiorcavity 24 includes a proximal portion 26 extending from adjacent theproximal end 20 to near the distal end 22, and a distal cavity 28adjacent distal end 22. The proximal portion 26 includes a first, uppersection 29 which is shaped according to luer taper standards so as tomatingly receive a luer taper 30 (FIGS. 9 and 10) therein, and a second,lower section 31 which has a relatively constant cross dimension (e.g.,diameter) that is generally greater than at least the smallest, taperedcross dimension of the first section 29 with a transition region 32being generally defined therebetween.

The catheter tube 14 includes a proximal end 34, a tapered distal end35, and an open passageway 36 extending therebetween. The proximal end34 of the catheter tube 14 is secured within the distal cavity 28 of thecatheter hub 12 using the actuator 16 so that the catheter tube 14extends distally of the catheter hub distal end 22. Thus, the actuator16 not only supports the seal member 18 and facilitates its opening, butthe actuator 16 also serves the function of securing the catheter tube14 to the catheter hub 12.

Catheter assembly 10 is advantageously utilized as part of a PIVC 38, aportion of which is shown in FIG. 2 in a ready position of the PIVC 38.To that end, a needle cannula 40 has a shaft 41 and extends distallyfrom a nose 42 to a sharp distal tip 43. The nose 42 extends into theupper section 29 of the interior cavity 24 of the catheter hub 12. Inthe ready position as shown in FIG. 2, the needle cannula 40 extendsthrough the seal member 18, through the actuator 16, and through thecatheter tube 14 so as to expose the sharp distal tip 43 beyond thedistal end 35 of the catheter tube 14. In the embodiment shown in FIG.2, the needle cannula 40 is axially slidable through the nose 42 suchthat the needle cannula 40 can be withdrawn proximally from the cathetertube 14 and the seal member 18 without necessarily proximallywithdrawing the nose 42 from the catheter hub 12 until the needlecannula 40 is to be completely removed from the catheter assembly 10.Nose 42 may extend from a cap or flange 44 of a protector, one exampleof which is the needle guard housing 45 (only a portion of which isshown, in phantom, in FIG. 2) of a ProtectIV® PIVC available from SmithsMedical ASD, Inc. Other types of protectors (not shown) may be used withPIVC 38 as will be readily understood by those skilled in the art. Inanother embodiment (not shown), the nose and the needle cannula aresecured together so as to move as one such that proximal withdrawal ofthe needle cannula necessarily also withdraws the nose from the catheterhub 12. In that embodiment, the nose serves as a needle hub or supportfor the needle cannula as exemplified by the JELCO® PIVC also availablefrom Smiths Medical ASD, Inc. Other examples of needle cannula and nosecombinations are shown in U.S. patent Publication No. 2007/0191775, thedisclosure of which is incorporated herein by reference in its entirety.

With further reference to FIG. 3, actuator 16 is generally rigid andincludes a generally cylindrical main shaft 46 with an outer surface 47,a distal eyelet portion 48 at a distal end 49, and a proximal barb 50 atan opposite, proximal free end 51. An open passageway 52 extends betweenthe free end 51 and the eyelet portion 48 to receive the needle cannula40 therethrough, and for flow of fluid therethrough when the seal member18 is in the opened position. The distal eyelet portion 48 is similar toa conventional eyelet and, for large gauge needle cannula 40, such as20, 22, 24, and/or 26 gauge needle cannula 40, includes an eyelet shaft53 and a head 54 that merges into the main shaft 46 at an intersection55. The eyelet shaft 53 has a cross dimension that is substantiallysmaller than a cross dimension of the main shaft 46 so as to be closelysized to the diameter of the needle cannula 40. The barb 50 at theproximal free end 51 may be characterized by having a maximum crossdimension generally greater than the cross dimension of the main shaft46 (and thus also of the eyelet shaft 53) and may include an enlargedflange 56 that essentially folds back over a portion of the main shaft46 and diverges in a distal direction to define a frustoconical outersurface 57 that is radially outward of the main shaft 46.

As illustrated in FIG. 1, the distal eyelet portion 48 of actuator 16 isfrictionally fit within the catheter hub distal end 22, such as indistal cavity 28, to secure the catheter tube 14 to the catheter hub 12.Unlike a conventional eyelet, however, the main shaft 46 of actuator 16extends proximally from the catheter hub distal end 22 such that adistal portion 60 thereof frictionally engages with a portion 62 of thedistal cavity 28 as at 63 to assist in securing the actuator 16 to thecatheter hub 12, and further such that the proximal free end 51 isspaced from the distal end 22 but remains disposed within the interiorcavity 24 of catheter hub 12. More particularly, the main shaft 46 ofthe actuator 16 extends out of the distal cavity 28 and into theproximal portion 26 of the interior cavity 24, but the proximal free end51 of the actuator 16 does not extend to the proximal end 20 of thecatheter hub 12 and instead terminates distally thereof. In theembodiment shown, for example, the proximal free end 51 terminateswithin the second section 31 of the interior cavity 24. Additionally,the radial cross dimension of the actuator 16, including, for example,the barb 50 thereof, is smaller than the cross dimension of the secondsection 31 of the interior cavity 24 proximal of distal cavity 28 so asto generally define an annular space 64 between the inner wall 25 of thecatheter hub 12 and the actuator 16. As will be discussed in more detailbelow, the annular space 64 is configured to receive the seal member 18as it is moved toward the opened position.

To enhance securement of the actuator 16 to the catheter hub distal end22, the actuator 16 may include a surface feature formed thereon such asone or more dimples 65 a in the outer surface 47 in the distal portion60 of the main shaft 46 spaced near eyelet portion head 54 (FIG. 3A),one or more axial scribe lines or grooves 65 b in the outer surface 47extending along the distal portion 60 of the main shaft 46, and possiblyinto the eyelet portion 54 (FIG. 3B), or one or more annular grooves 65c in the outer surface 47 and along the distal portion 60 of the mainshaft 46 (FIG. 3C). The surface feature is configured to interact withthe catheter hub portion 62 as at 63 to increase frictional engagementtherebetween.

The actuator 16 as shown in FIG. 3 is advantageously configured forsmall diameter needle cannula 40, such as gauges 20 through 26. Wherethe diameter of the needle cannula 40 is large, such as gauges 16 or 18,an alternative embodiment of actuator 16 a may be provided as shown inFIG. 4 (where like numbers represent like features as in actuator 16).To that end, the eyelet shaft 53 a of the eyelet portion 48 a will havea cross dimension that is possibly the same as (such as for a 16 gaugeneedle cannula 40) or only slightly smaller than (for a 18 gauge needlecannula 40) the cross dimension of the main shaft 46. In thatcircumstance, securement of the actuator 16 a may be enhanced byproviding a surface feature to the actuator 16 a in the form of aradially outwardly extending annular rib 65 d which may provide a crossdimension about 12% larger than the cross dimension of the main shaft46. Advantageously, rib 65 d is in the form of a sawtooth in crosssection (FIG. 4A), but it could also be more rounded. Annular rib 65 dis advantageously located on the distal portion 60 of the main shaft 46,and may overlap into the intersection 55 a thereof with the eyeletportion 48 a. Where actuator 16 a is used, the area of catheter hub 12at 62 may be provided with a radially outwardly extending notch (notshown) sized with a cross dimension which may be smaller than that ofthe annular rib 65 d so as to form a tight fit therebetween.Alternatively, the notch may be sized with a cross dimension slightlylarger than that of the annular rib 65 d such that the rib 65 d may bepositioned within the notch more easily, but yet still effectivelysecure the actuator 16 a to the catheter hub 12.

The actuators 16, 16 a may be formed from suitable materials includingvarious metals and plastics and may be formed as a unitary or monolithicmember. In alternative embodiments, however, the actuators 16, 16 a maybe formed from separate members which are subsequently coupled, such asthrough a welding or bonding process, to form the actuator. In anexemplary embodiment, the actuators 16, 16 a may be formed from medicalgrade stainless steels (e.g., 410 stainless steel, 17-7 stainless steel,etc.) through processes generally known in the art.

As seen in FIG. 1, the seal member 18 is disposed within the interiorcavity 24 of the catheter hub 12 and is supported therein at least inpart by the actuator 16. The seal member 18 may also be supported inpart by the inner wall 25 of catheter hub 12, as will be explainedbelow. With further reference to FIGS. 5 through 7, the seal member 18includes a generally cylindrical body 70 with an outer surface 71 and acentral membrane 72, a distal portion 74 extending distally from themembrane 72 and terminating in a distal end 75, and a proximal portion76 extending proximally from the membrane 72 and terminating in aproximal or impact end 77. The membrane 72 extends substantiallyperpendicularly relative to a central axis 78 and along a planecentrally located between proximal and distal ends 77, 75 of the sealmember 18. In one embodiment, the membrane 72 has a generally constantaxial thickness having generally planar upper and lower surfaces 79, 80,respectively, and includes a normally-closed slit 82 that extendscompletely through the axial thickness of the membrane 72. In analternative embodiment, the upper and lower surfaces 79, 80 of membrane72 may not be planar, but may have other configurations including, forexample, concave or convex configurations.

The slit 82 may take several forms recognized in the art and could, forexample, be a single straight slit (not shown) through the membrane 72.Advantageously, and in the embodiment shown herein, the slit 82 has atri-slit configuration that extends to three radially outermost ends 83to present a Y-shape when viewed in plan view as shown in FIG. 7. Theslit 82 defines a plurality of membrane flaps 84, the number of whichdepends on the particular configuration of the slit 82 (e.g., threeflaps 84 for a tri-slit configuration). Additionally, the length of theslit 82 (e.g., its radial extent) is preferably less than a crossdimension (e.g., diameter) of the membrane 72 such that the radiallyoutermost ends 83 of the slit 82 are spaced from, and the slit 82 doesnot penetrate into, the inner surface 85 of the cylindrical body 70 ofthe seal member 18. In the ready position of the PIVC 38, the slit 82 inthe membrane 72 and the needle shaft 41 may cooperate so as to form asubstantially fluid tight seal about the needle shaft 41 when it extendsthrough the membrane 72 (FIG. 2). However, the slit 82 and needle shaft41 may not be fluid tight, but advantageously may still provide asignificant restriction to blood flow through the membrane 72 when theneedle shaft 41 extends therethrough, such that, for example, only a deminimus amount of blood may seep through the slit 82 of the membrane 72during insertion of the catheter tube 14 into the vasculature of apatient (not shown).

The distal portion 74 of the seal member 18 includes a sealing outletbore 86 defined by an annular sealing lip 87 extending proximally inwardfrom the distal end 75, and an actuator cavity 88 between the sealingoutlet bore 86 and the lower surface 80 of the membrane 72. The free end51 of the actuator 16 is receivable through the sealing outlet bore 86and into the actuator cavity 88 with the barb 50 contained in theactuator cavity 88 (FIG. 1). The actuator cavity 88 advantageouslyincludes a narrowed portion 89 that provides the actuator cavity 88 withan hourglass shape (FIG. 6). For example, the narrowed portion 89 may beprovided by an annular rib 90 projecting generally radially inward fromthe portion 93 of the inner wall 85 that defines the actuator cavity 88.In the closed position of the seal member 18 as shown in FIG. 1,frustroconical surface 57 of the actuator 16 engages with annular rib90.

The proximal portion 76 of the seal member 18 is advantageouslycylindrical and includes a generally cylindrical bore 92 extendingbetween the membrane 72 and an opening 94 at the proximal end 77. Thebore 92 may have a generally constant cross dimension along the lengththereof. The opening 94 into, and advantageously the cylindrical bore92, are configured such that neither the standard luer dimensioned nose,nor a standard dimensioned luer taper 30 (FIG. 9), can pass into thebore 92 but instead will, at most, impact against end 77. To that end,and as seen in FIG. 2, the nose 42 to be used with the catheter assembly10 shown herein has a proximal aspect 42 a defining a standard luertaper cross dimension so as to engage with wall 25 adjacent proximal end20 of the catheter hub, and a reduced cross dimension distal aspect 95with a uniform cross dimension along its length and sized to pass intothe bore 92. However, the length of distal aspect 95 is selected so thatthe distal end 96 thereof does not unduly press against upper surface 79of the membrane 72 in the ready position so as to avoid deformation ofthe membrane 72 which might adversely affect any seal between the slit82 and the shaft 41 of the needle cannula 40. A recessed bore 97 may beformed in the distal end 96 for purposes to be described.

The normal length of a nose that would extend into the luer taperedproximal section 26 of the catheter hub 12 is expected to provide areasonably reliably frictional engagement therebetween such that thenose does not fall out of the catheter hub 12, but can be easily removedtherefrom with a slight force by the clinician (not shown). Due to thereduced cross dimension distal aspect 95, there is not as muchengagement between the nose proximal aspect 42 a and the inner wall 25of the catheter hub 12. To avoid an unduly loose fit that mightotherwise obtain, the distal aspect 95 may advantageously be sized tofrictionally engage within the bore 92. Alternatively or additionally, aradially inwardly directed rib or projection(s) (not shown) may beformed on portion 98 of the inner wall 85 of the bore 92 to moresecurely engage with the distal aspect 95 of the nose 42.

The membrane 72 that closes the seal member 18 is located intermediatethe proximal and distal ends 77, 75 of the seal member 18 (i.e., not atone of its ends). In this regard, the seal member 18 may becharacterized by the membrane 72 having an axial thickness t that issubstantially less than each of the axial length l_(p) of the proximalportion 76 and the axial length l_(d) of the distal portion 74. By wayof example and without limitation, the axial lengths l_(p) and l_(d) mayrange between 7 to 15 times thickness t. In an exemplary embodiment, thethickness t of the membrane 72 may be about 0.015 to about 0.020 inches,while the lengths l_(p) and l_(d) may be approximately 0.235 inches andabout 0.155 to about 0.16 inches, respectively.

As shown in FIG. 1, in the closed position of the seal member 18, theactuator 16 extends through the sealing outlet bore 86 such that thebarb 50 is disposed within the actuator cavity 88. More particularly,the sealing lip 87 of the sealing outlet bore 86 is in sealingengagement with the outer surface 47 of the actuator main shaft 46 so asto substantially seal the actuator cavity 88 from below. The main shaft46 of the actuator 16 is advantageously sized in cross dimension toreceive the largest diameter needle cannula that might be employed withcatheter assembly 10, with the eyelet portion 48 or 48 a thereof sizedto conform more closely to the specific needle cannula 40. As aconsequence, the sealing outlet bore 86 can be a common size across thespectrum of needle cannula such that the same seal member 18 can be usedacross the range of expected needle cannula gauges, rather thannecessarily requiring a different seal member 18 for each gauge, or agroup of gauges.

Additionally, the barb 50 is completely contained in the actuator cavity88 and may be in engagement with the narrowed portion 89 as explainedearlier. The barb 50 has an outermost cross dimension larger than across dimension of the sealing outlet bore 86 and is configured to allowthe sealing outlet bore 86 to be slid distally over the barb 50, butrestricts proximal movement of the seal member 18 back over the barb 50.

In the closed position, the seal member 18 is completely disposed withinthe interior cavity 24 of the catheter hub 12 so as to be spaced fromboth the proximal and distal ends 20, 22 thereof. To that end, theproximal end 77 of the seal member 18 is spaced from the opening 21 atthe proximal end 20 of the catheter hub 12 by a distance d_(p) so as todefine a space P1 proximal of the seal member 18, and the distal end 75of the seal member 18 is spaced from the distal cavity 28 of thecatheter hub 12 by a distance d_(d) so as to define a space D1 distal ofthe seal member 18. In an exemplary embodiment, d_(p) may be about 0.045inches and d_(d) may be between about 0.085 and about 0.17 inches.Additionally, the membrane 72 is positioned proximally of the free end51 of the actuator 16 such that the normally-closed slit 82 formedtherein substantially seals the actuator cavity 88 from above.Accordingly, and as will be explained in more detail below, should bloodflow into actuator cavity 88 of the seal member 18 during insertion ofthe catheter assembly 10, for example, the actuator cavity 88 issubstantially fluidly isolated (e.g., sealed) from below by the sealinglip 87/actuator wall 47 engagement and above by the normally-closed slit82 of the membrane 72 such that substantially no blood can flowtherebeyond and into the interior cavity 24 of the catheter hub 12.

In some previously proposed designs, an elongated member extends intothe catheter hub and the seal is pushed thereagainst to open same. Butthe seal in those proposed designs has typically either been freelyfloating on the elongated member so as to be spaced along its entirecircumference from the catheter hub wall, or the seal is in fullcircumferential engagement with the wall of the catheter hub. Eachapproach is considered to present disadvantages. Free floating seals maylack sufficient support within the catheter hub and may be subject toundue sideways or similar movement or tilting. Seals that are in fullcircumferential engagement with the catheter hub wall may suffer fromrelatively large friction forces at the seal/catheter hub wallinterface, and may therefore require a relatively large force to movethe seal to the opened position during actuation. These types of sealsmay have other shortcomings as well. For example, due to the fullcircumferential engagement, pressure build ups are possible when theseal is actuated because air, for example, cannot escape the spacedistally of the seal as it is being moved axially within the catheterhub into that space. Such pressure build ups are undesirable and mayrequire unduly large actuation forces to operate.

In accordance with another feature of the present invention, seal member18 is supported by both the actuator 16 and the catheter hub 12, but inthe closed position, the outer surface 71 is only in partialcircumferential engagement with the inner wall 25 of the catheter hub 12along an outer contacting region 100 thereof (FIG. 1) so as to maintainat least one air path 102 (as exemplified by arrows 102 in FIG. 1)between the spaces P1 and D1 proximal and distal, respectively, of theseal member 18. Advantageously, two such air paths 102 are provided. Tothat end, at least along the contacting region 100 of the seal member18, the outer surface 71 of the seal member 18 may include at least oneaxially-directed channel or groove 104 extending inwardly from the outersurface 71 and which defines a portion, if not the entirety, of the airpath 102 therealong. Where two or more axial grooves 104 are provided,each defines a portion, or the entirety, of a respective air path 102.Advantageously, only a short axial portion of the outer surface 71 isengaged in contacting region 100, such that the areas proximal anddistal thereof are spaced away from the inner wall 25 of the interiorcavity 24 as at 105 and 106 as illustrated for example in FIG. 1. Theareas 105 and 106 also define a portion of the air path(s) 102, and havethe further advantage of reducing friction between the seal member 18and the catheter hub 12 so that the seal member 18 is more readilyslidable within the catheter hub 12 to open same as will be describedbelow. Provision of the air path(s) 102 allows the outer surface 71 ofthe seal member 18 to be in circumferential engagement with the innerwall 25 of the catheter hub 18 in the engagement area 100, except in thearea of the axial groove(s) 104 so as to define a partialcircumferential engagement. As a consequence, the seal member 18 is heldin a stable position on the actuator 16, but also facilitates fluidcommunication between areas P1 and D1 of the interior cavity 24 proximaland distal of the seal member 18 so as to prevent excessive pressurebuild up during actuation of the seal member 18 and to reduce thesurface area contact between the seal member 18 and the inner wall 25 ofthe catheter hub 12 thereat to thus minimize frictional forces imposedon the seal member 18 during actuation.

The distal area 106 may be achieved by reducing the outer crossdimension of the seal member 18 along the distal portion 74 thereofand/or increasing the cross dimension of the second section 31 of theinterior cavity 24 adjacent the distal portion 74 of the seal member 18.Similarly, the proximal area 105 may be achieved by reducing the outercross dimension of the seal member 18 along the proximal portion 76thereof and/or increasing the cross dimension of the first section 29 ofthe interior cavity 24 of the sealing member adjacent the proximalportion 76 of the sealing member 18. For example, the proximal area 105may be a result of the luer tapering of the first section 29 of theproximal portion 26 of the interior cavity 24 while maintaining theouter cross dimension of the proximal portion 76 of the seal member 18relatively constant, as shown in FIG. 1.

The contacting region 100 between the seal member 18 and catheter hub 12may occur along the membrane 72 and the distal-most portion of theproximal portion 76 of the sealing member 18. Notably, however, theaxial groove(s) 104 extend at least from a location distal of thecontacting region 100 to a location proximal of the contacting region100. Accordingly, depending on the particular size of the contactingregion 100, the axial groove(s) 104 may extend the full length of theseal member 18 or for only a portion thereof (so long as they extendaxially sufficiently to define any portion of the associated air path102 through the engagement area 100, whether they extend therebeyond isnot controlling, but may be advantageous). In one embodiment, each axialgroove 104 is open to the distal end 75 of the seal member 18, but stopsshort of extending to the proximal end 77 thereof (FIG. 6). Moreover,the depth of the axial groove(s) 104 is such as to not penetrate throughthe inner surface 85 of the seal member 18 in either the sealing outletbore 86 or the actuator cavity 88, as well as, advantageously, in bore92.

With further regard to FIG. 2, the cap 44 is sized such that it does notfit within the proximal opening 20 of the catheter hub 12. Instead, thecap 44 may abut a proximal end face 110 of the catheter hub 12 when thePIVC 38 is in the ready position. The cap 44 may also include acontinuous or segmented collar or rim (not shown) adapted to fit over,and possibly releaseably engage, external luer lock receiving ears 112of the catheter hub 12 defined adjacent end face 110. Advantageously, inthe ready position, the cap 44 is against end face 110 and the nose 42extends into the interior cavity 24 with proximal aspect 42 a thereoffitting snugly against the inner wall 25 of the catheter hub 12. Thedistal segment 95 is sized so as to fit within the bore 92 such that thedistal end 96 is adjacent or engaging the upper surface 79 of membrane72. In the event the distal end 96 contacts the membrane 72, it does notpenetrate through the slit 82 thereof. Additionally, the bore 97 at thedistal end 96 is positioned so as to overlie the slit 82 in the membrane72.

In use, and from the ready position as illustrated in FIG. 2, the sharptip 43 of PIVC 38 is inserted into the artery or vein of the patient(not shown) in the conventional manner. The needle shaft 41 may includea slot 114 therethrough adjacent the sharp tip 43 to provide bloodflashback. The use of the slot 114 in the needle cannula 40 may bepartially advantageous for large gauge needle cannula 40 (i.e., smallerdiameter needle cannula 40). In addition to, or in lieu of, the cannulaslot 114, the needle cannula 40 may couple to a flash chamber (notshown) adjacent the proximal end (not shown) of the needle cannula 40for blood flashback as is conventional.

After insertion of the catheter tube 14 into the patient, the needlecannula 40 is withdrawn proximally from the catheter tube 14 and thecatheter hub 12 while leaving the catheter assembly 10 in fluidcommunication with the vasculature of the patient. As the needle cannula40 is being withdrawn, the drag force imposed on the seal member 18(e.g., on the slit 82 of the membrane 72) due to the proximal movementof the needle cannula 40 is insufficient to overcome the forcesretaining the seal member 18 in the catheter hub 12. Accordingly, theseal member 18 remains positioned within the catheter hub 12 duringproximal withdrawal of the needle cannula 40. More particularly, theforce imposed by the sealing lip 87 on the actuator 16 (which is fixedlysecured to the catheter hub 12 as previously described), the frictionforce of the seal member 18 engaging the inner wall 25 of the catheterhub 12 along contacting region 100, as well as any friction forcesgenerated between the barb 50 and the inner wall 85 of the actuatorcavity 88 may individually or collectively resist proximal movement ofthe seal member 18 relative to the catheter hub 12 upon withdrawing theneedle cannula 40. Even if there should be some initial proximalmovement of the seal member 18 relative to the catheter hub 12, the barb50 of actuator 16 is larger than the sealing outlet bore 86 of sealmember 18 such that any initial axial movement of the seal member 18would be arrested.

Furthermore, during proximal withdrawal of the needle cannula 40, thedrag force acting on the slit 82 of the membrane 72 may cause one ormore of the flaps 84 formed by the slit 82 to slightly flex or distendupwardly (i.e., proximally). More particularly, the slot 114 may engagewith one of the flaps 84 as it passes proximally through the slit 82 toflex or distend the flap 84. The nose 42 remains within the catheter hub12 during such withdrawal, such that the upward flexing of the flaps 84is into the recessed bore 97 as shown in FIG. 8, rather than against thedistal end 96 of the nose 42, thereby reducing the risk of damage to theflaps 84 and the negative affect that might have on the sealingcapability of the slit 82. Where the nose 42 and the needle cannula 40are secured such that the nose 42 moves with proximal movement of theneedle cannula 40, the recessed bore 97 may be omitted.

In addition to the above, the drag force on the seal member 18 generatedby withdrawing the nose 42 from the catheter hub 12 is also insufficientto overcome the forces retaining the seal member 18 in the catheter hub12. Thus, for example, the slip fit between the reduced cross sectiondistal aspect 95 of the nose 42 and the bore 92 of the seal memberproximal portion 76 is not so tight as to cause the seal member 18 to bepulled out of the catheter hub 12 during proximal withdrawal of the nose42 from the catheter hub 12. Similar to above, even if there should besome initial proximal movement of the seal member 18 relative to thecatheter hub 12, the barb 50 of the actuator 16 is larger than thesealing outlet bore 86 of the seal member 18 such that any initialproximal movement of the seal member 18 would be arrested.

After the needle cannula 40 has been withdrawn and the nose 42 separatedfrom the catheter assembly 10, the seal member 18 within the catheterhub 12 is in the closed or sealed position to prevent blood from thepatient from flowing into the interior cavity 24 of the catheter hub 12(FIG. 1). More particularly, during and after insertion of the cathetertube 14 into the patient's vasculature (e.g., during proximal withdrawalof the needle cannula 40, or after the needle cannula 40, and possiblythe nose 42, have been proximally withdrawn from the catheter hub 12),blood from the patient may flow up through the catheter tube 14, throughthe actuator 16, and into the actuator cavity 88 of the seal member 18,in which the proximal free end 51 of the actuator 16 is disposed. Inother words, an unobstructed fluid flow path exists between the distalend 35 of the catheter tube 14 and the proximal free end 51 of theactuator 16 such that blood may flow therebetween. Advantageously,however, blood that flows into the actuator cavity 88 is substantiallyprevented from flowing out of the cavity 88 such that hemostasis isachieved or maintained.

To this end, the sealing lip 87 of the outlet bore 86 forms asubstantially fluid tight seal with the outer surface 47 of the actuatormain shaft 46 to prevent any blood flow out of actuator cavity 88 alongthis interface (e.g., the actuator cavity 88 is effectively sealed frombelow). Additionally, after the needle cannula 40 has been removed fromthe membrane 72, the slit 82 closes due to the resiliency of thematerial that forms the membrane 72 (i.e., the slit 82 is normallyclosed). The closing of the slit 82 substantially prevents blood flowout of the actuator cavity 88 through the membrane 72. Advantageously,the slit 82 is sufficiently closed so that essentially no blood seepsthrough the slit 82 and past the membrane 72 under the pressuresnormally observed during use.

As noted above, even if there should be some seepage through the slit 82of the membrane 72, the amount of blood would be de minimus andhemostasis during and after insertion of the catheter tube 14 (but priorto actuation of seal member 18) would still be sufficiently maintained.Accordingly, should blood flow into actuator cavity 88 of the sealmember 18, the cavity 88 is substantially fluidly isolated (e.g.,sealed) from below by the sealing lip 87/actuator surface 47 engagementand above by the closed slit 82 of the membrane 72 such thatsubstantially no blood can flow therebeyond. This allows medicalpersonnel to address other pressing issues without worry that blood isgoing to flow out of the catheter hub 12 in the interim.

The seal member 18 is configured to not only provide blood controlduring use, but the seal member 18 is further configured to be actuatedso as to open a fluid flow path from the catheter tube 14.Advantageously, and as illustrated in FIGS. 9 and 10, the seal member 18may be configured such that it is axially shiftable so as to slideaxially along the main shaft 46 of the actuator 16, to the openedposition. That shifting is accomplished by insertion of a male luertaper 30 into and through the proximal end 20 of the catheter hub 12such that the free or distal end 120 thereof impacts surface proximalend 77 of the seal member 18 and pushes the seal member 18 distally withenough force to overcome the friction forces holding the seal member 18in place. To that end, the luer taper 30 may be associated with a luerlock collar or nut 122 adapted to threadably engage catheter hub ears112 so as to impel the luer taper 30 against proximal end 77. Thatcauses the luer taper 30 to push thereagainst over a travel distancewhich axially shifts the seal member 18 driving the membrane 72 over theactuator barb 50 and distending the flaps 84 placing the seal member inthe opened condition. The catheter assembly 10 is configured such thatthe entire seal member 18 axially shifts distally within the catheterhub 12.

As the seal member 18 axially shifts within the catheter hub 12, theproximal free end 51 of the actuator 16 contacts the lower surface 80 ofthe membrane 72 and starts penetrating through the slit 82 causing theflaps 84 formed by the slit 82 to hinge or distend upwardly and slidealong the barb 50, such as along the frustoconical surface 57 thereof,so as to gradually open the slit 82. Continued distal insertion of theluer taper 30 causes the seal member 18 to shift axially until the luertaper 30 is fully extended into the interior cavity 24 with the distalend 75 of the seal member 18 moved toward, or against, distal cavity 28to thus define the open position of the seal member 18 as shown in FIG.10. In one embodiment, the membrane 72 is sufficiently resilient suchthat the barb 50 may penetrate the slit 82 without ripping or otherwisedestroying the membrane 72. The slit 82 may then close back down aroundthe actuator main shaft 46 after the barb 50 passes therethrough. In analternative embodiment, the membrane 72 may be deformed, or may beripped or otherwise destroyed, as the barb 50 penetrates through theslit 82. This is illustrated, for example, by the broken appearance ofthe membrane 72 in FIG. 10.

In the opened position of the seal member 18, an unobstructed fluid pathis established between the catheter tube 14 and the luer taper 30 viathe actuator 16 such as for administration of fluids to, or withdrawalof blood from, the patient with the catheter assembly 10.Advantageously, the seal member 18 and the catheter hub 12 are sizedsuch that in the opened position, the seal member 18 is not under axialcompression, i.e., the seal member 18 is not being axially squeezedbetween the luer taper 30 and the distal end 22 of the catheter hub 12.In this regard, the travel distance d_(t) of the seal member 18 betweenthe closed and opened position is configured to be less than thedistance d_(d) between the distal end 75 of the seal member 18 and thedistal cavity 28 of the catheter hub 12. In an exemplary embodimentwhere d_(d) is about 0.17 inches, the travel distance d_(t) may beapproximately 0.163 inches. The invention, however, is not so limited asin an alternative embodiment, there may be some axial compression on theseal member 18 when in the opened position.

In the embodiment shown and described herein, the seal member 18 is aone-time use seal. In this regard, after removal of the luer taper 30from the catheter hub 12, the seal member 18 will not move backproximally to the closed position, but will instead remain in the openedposition. More particularly, the barb 50, while configured to permitmovement of the seal member 18 in the distal direction, discouragesmovement of the seal member 18 in the opposite, proximal direction.Thus, the membrane 72 in the embodiment shown does not automaticallymove back over the barb 50 to close off the fluid flow path establishedwith the catheter tube 14 which instead now provides an unobstructedfluid flow path between the catheter tube 14 and interior cavity 24and/or the open proximal end 20 of the catheter hub 12. Although notshown, in another embodiment, the catheter assembly could be providedwith a mechanism, such as a spring, elastic, or bellows, to provide adriving force axially shifting the seal member 18 back in the proximaldirection to reclose the seal member 18. However, in the embodimentshown herein, the seal member 18 is a one-time use seal for providinghemostasis and once it is opened, it is not intended to be reclosed.

The seal member 18 may be generally flexible and be formed from suitablematerials including, for example, silicone or polyisoprene. In oneembodiment, the seal member 18 may be formed as a unitary or monolithicmember through various molding processes including, for example,injection molding processes generally known in the art. The slit 82 isgenerally not molded into membrane 72, but is instead formed in apost-molding process. In this regard, and as illustrated in FIGS. 11 and12, a punch or slit tool 160 may be used to form the tri-slit 82 in themembrane 72. Conventional tools for creating a tri-slit (not shown)generally include a flat-headed punch having a shape corresponding tothe shape of the tri-slit. Such tools, however, when used on resilientmaterials often stretch the material during the punching operation suchthat sufficient support must be provided directly beneath the materialbeing slit to prevent tearing or causing other damage.

To overcome such a drawback, the slit tool 160 includes a distal end 161formed by a three-sided pyramid 162 having a base 164 with three corners165 at one end 166 thereof, and terminating in a pointed tip 168 at theother end 169 thereof so as to define three diverging surfaces 170 ofthe pyramid 162. The tool 160 further includes a shaft 172 havinggenerally straight, sharpened edges 173 with generally planar lands 174therebetween. The pyramid 162 is coupled to the shaft 172 such that theedges 173 generally axially align with the respective corners 165 of thebase 164. As shown in FIG. 12, to form the tri-slit 82, the molded sealmember 18 may be placed in a fixture 180 having a bore 182 sized toreceive the seal member 18 therein. The bore 182 includes a bottom wall184 configured to engage the distal end 75 of the seal member 18 withinthe fixture 180. The tool 160 is inserted through the proximal opening94 of the bore 92 in the seal member 18 so as to engage the pointed tip168 against the upper surface 79 of the membrane 72. Insertion of thetool 160 is continued such that the pointed tip 168 and the divergingsurfaces 170 ease, at least partially, through the seal member 18 so asto gradually increase the length of the slit 82 until the desiredtri-slit configuration is achieved. It should be realized that in analternative embodiment, the seal member 18 may be inverted withinfixture 180 such that the proximal end 77 of the seal member 18 engagesthe bottom wall 184 and the tool 160 is inserted through the sealingoutlet bore 86 and actuator cavity 88 so as to engage against the lowersurface 80 of the membrane 72. In either orientation of the seal member18 within fixture 180, the membrane 72 need not be directly supported,although a support (not shown) may be provided beneath the membrane 72if desired. The configuration of the tool 160 provides for a clean slit82 and reduces the likelihood of damaging the seal member 18 during theslit-forming process.

The catheter assembly 10 may be assembled as follows. The actuator 16may be inserted through the proximal opening 21 of the catheter hub 12such that the distal eyelet portion 48 or 48 a captures the proximal end34 of the catheter tube 14 within the distal cavity 28 of the catheterhub 12. Alternatively, the proximal end 34 of the catheter tube 16 maybe coupled to eyelet portion 48, 48 a of the actuator 16, 16 a and thatsubassembly inserted through the proximal opening 21 of the catheter hub12 so as to capture the proximal end 34 of the catheter tube 16 withinthe distal cavity 28. In either embodiment, the actuator 16, 16 a willbe situated to project proximally from the distal end 22 of the catheterhub 12 within the interior cavity 24. The seal member 18, which may beformed by the method described above, is threaded onto the needlecannula 40. In one embodiment, the sharp tip 43 thereof may simply beinserted through the slit 82 in membrane 72 and the seal member 18threaded onto the needle shaft 41. In an alternative embodiment, theneedle cannula 40 may be extended through the membrane 72 in a mannerthat reduces potential damage to the membrane 72. To this end, a smalltube (not shown) may first be inserted through the slit 82. The smalltube is configured to be generally smooth (e.g., devoid of any sharpedges, burrs, etc.) and relatively soft and may be formed of a suitableplastic material. After positioning the tube through the slit 82, theneedle cannula 40 may then be inserted through the tube such that thesharp tip 43 cannot directly engage the membrane 72 as the needlecannula 40 is extended through the slit 82. Thereafter, the tube ispulled out of the slit 82 and over the needle cannula 40, such as overthe sharp tip 43 thereof, allowing the slit 82 and needle shaft 41 toengage. In this way, the tube acts as a barrier between the membrane 72and the needle cannula 40 during inserting of the needle cannula 40through the slit 82 so as to avoid or reduce the likelihood of damageduring assembly.

Once threaded onto needle shaft 40, the seal member 18 may be slidablypositioned on the nose 42 with the distal aspect received in the bore 92in proximal portion 76 of the seal member 18 in a slip fit, which mayrange from being relatively snug to providing just enough engagement tofrictionally retain the seal member 18 on the nose 42. The distal aspect95 of the nose 42 may be inserted into the bore 92 until the proximalend 77 of the seal member 18 abuts the annular shoulder 190 at theintersection of the nose aspects 42 a and 95. When this occurs, thedistal aspect 95 of the nose 42 may engage, or be slightly spaced from,the upper surface 79 of the membrane 72. In an alternative embodiment,the distal aspect 95 may be inserted into bore 92 until the distal end96 thereof abuts the upper surface 79 of the membrane 72. When thisoccurs, the proximal end 77 of the seal member 18 may be slightly spacedfrom the annular shoulder 190. It will be readily understood that theneedle cannula 40 may be retracted and the seal member 18 placed on thenose 42 prior to threading the needle cannula 40 to the seal member 18as described above.

After the seal member 18 is disposed on the nose 42 and the needlecannula 40 extends distally thereof, the catheter assembly 10 may beloaded onto the nose 42 such that the seal member 18 is positionedwithin the catheter hub 12. In this regard, as the catheter assembly 10and nose 42 are moved together, the sealing outlet bore 86 contacts thebarb 50 and sealing lip 87 flexes outwardly (e.g., due to cammingengagement of the sealing lip 87 and the frustoconical surface 57 of theflange 56) to allow the barb 50 to pass through the sealing outlet bore86 and into the actuator cavity 88. When the sealing outlet bore 86moves past the barb 50, the sealing lip 87 flexes or snaps back radiallyinwardly due to the resiliency of the seal member 18 and engages theouter surface 47 of the actuator 16 distal of the barb 50 to form asubstantially fluid tight seal therealong.

The catheter assembly 10 and nose 42 may be moved further together untilthe cap 44 abuts the proximal end face 110 of the catheter hub 12.During this further movement, the sealing lip 87 of the sealing outletbore 86 slides along the outer surface 47 of the actuator 16 andmaintains the substantially fluid tight seal therealong. When the cap 44and the catheter hub 12 engage, the seal member 18 is configured to beproperly seated on the actuator 16 within the catheter hub 12 in theready position. In this ready position, the barb 50 may engage thenarrowed portion 89 of the actuator cavity 88 to provide a level ofresistance to further distal movement of the seal member 18 relative tothe actuator 16. During assembly, this resistance may also provide apositive indication that the seal member 18 is fully seated on theactuator 16.

While the present invention has been illustrated by the description ofembodiments thereof, and while the embodiments have been described inconsiderable detail, it is not intended to restrict or in any way limitthe scope of the appended claims to such detail. Additional advantagesand modifications will readily appear to those skilled in the art. Forexample, in some applications, it may be desirable to enhance thesecurement of the seal member 18 within the catheter hub 12 such as witha retention mechanism which may be in the form of a radially inwardannular rib (not shown) associated with the catheter hub inner wall 25which mates with a corresponding annular groove (also not shown) in theseal member 18 in the closed position. However, when the male luer taper30 is inserted into the catheter hub 12, as described above, thisengagement is also overcome to allow the seal member 18 to be axiallyshifted to the opened position. Further, alternative assembly processesmay be employed, one example of which utilizes a tool (not shown) havinga shape similar to the nose 42 to insert the seal member 18 within thecatheter hub 12. Once the tool positions the seal member 18 within thecatheter hub 12, it may be removed therefrom. By way of further example,while slit 82 may be pre-cut into the membrane 72, the membrane 72 mightnot be pre-slit, but instead, may be pierced by the sharp tip 43 of theneedle cannula 40 during assembly. When the needle cannula 40 iswithdrawn from the membrane 72, the hole (not shown) caused by thatpiercing is capable of reclosing due to the resiliency of the membrane72 so as to provide hemostasis. Even if the hole does not completelyclose, however, the hole would provide a significant restriction toblood flow through the membrane such that, for example, only a deminimus amount of blood would pass through the membrane 72 under normaluse. It will be understood that the amount of force needed to actuatethe seal member 18 may be slightly higher, and could also lead topermanent deformation or damage of the membrane 72 as the seal member 18is moved to the opened position. Where the seal member is a one-time useseal as advantageously provided herein, such deformation or damage isnot considered problematic. Furthermore, while the seal member 18 isdescribed as a unitary member in the exemplary embodiment shown herein,in an alternative embodiment, the seal member may have a multi-piececonstruction. By way of example, the seal member may include a rigidretainer portion coupled to a resilient seal portion. The rigidretaining portion may be similar to the proximal portion 76 of the sealmember 18 described above in that it may be generally cylindrical andinclude a nose receiving bore like bore 92 extending therethrough. Theresilient seal portion may be similar to the membrane 72 and the distalportion 74 of the seal member 18 as described above. The resilient sealportion may be coupled to a distal end of the retainer portion andcollectively have a shape similar to the seal member 18 above. The rigidretaining portion is configured to accommodate the stresses and forcesimposed by the impact from the male luer taper 30, while the resilientseal portion is configured to provide the hemostasis function andaccommodate passage of the barb 50 of the actuator 16 through themembrane 72 during actuation. The invention in its broader aspects is,therefore, not limited to the specific details, representative apparatusand method, and illustrative examples shown and described. Accordingly,departures may be made from such details without departing from thespirit or scope of the general inventive concept.

Having described the invention, what is claimed is:
 1. A catheterassembly comprising: a catheter hub having an open proximal end and adistal end defining an interior cavity therebetween, with a cathetertube extending distally from the catheter hub distal end; a rigidactuator extending proximally in the interior cavity of the catheter hubfrom the catheter hub distal end to a free end, the actuator having anenlarged proximal flange at the free end thereof; a seal member disposedin the interior cavity of the catheter hub, the seal member including amembrane and a distal portion extending distally from the membrane to asealing outlet bore, the distal portion having an actuator cavitytherein between the membrane and the sealing outlet bore, the actuatorcavity having a narrowed portion defining an hourglass shape thereto,the actuator extending through the sealing outlet bore into the actuatorcavity with the proximal flange engaged against the narrowed portion ofthe actuator cavity, the proximal flange of the actuator beingcompletely contained within the actuator cavity and having an outercross dimension larger than a cross dimension of the sealing outletbore; and a needle cannula having a sharp distal tip, the needle cannulaextending through the seal member and catheter tube with the sharpdistal tip being exposed distally of the catheter tube.
 2. The catheterassembly of claim 1, the actuator having a shaft, the shaft sized to fitsealingly within the sealing outlet bore.
 3. The catheter assembly ofclaim 2, the proximal flange of the actuator being completely containedwithin the actuator cavity and having an outer cross dimension largerthan a cross dimension of the sealing outlet bore.
 4. The catheterassembly of claim 1, the membrane being normally closed to seal theactuator cavity, the seal member being axially slidable along theactuator to force the membrane over the proximal flange and open themembrane.
 5. The catheter assembly of claim 4, the membrane being slitto define slit flaps adapted to distend as the membrane is forced overthe proximal flange.
 6. The catheter assembly of claim 5, the sealmember including a proximal portion extending proximally from themembrane, and sized to present an impact surface to a free end of a luertaper, such that insertion of a luer taper into the catheter hubinterior cavity impacts the impact surface of the seal member causingthe seal member to slide axially along the actuator and distend the slitflaps.
 7. The catheter assembly of claim 4, the seal member including aproximal portion extending proximally from the membrane, and sized topresent an impact surface to a free end of a luer taper, such thatinsertion of a luer taper into the catheter hub interior cavity impactsthe impact surface of the seal member causing the seal member to slideaxially along the actuator.
 8. The catheter assembly of claim 1 furthercomprising a nose extending into the catheter hub interior cavity, theneedle cannula extending distally of the nose.
 9. The catheter assemblyof claim 1, the seal member being a unitary member.
 10. A catheterassembly comprising: a catheter hub having an open proximal end and adistal end defining an interior cavity therebetween, with a cathetertube extending distally from the catheter hub distal end; a rigidactuator extending proximally in the interior cavity of the catheter hubfrom the catheter hub distal end to a free end; a seal member disposedin the interior cavity of the catheter hub and supported by theactuator, the seal member having a membrane being slit to define slitflaps; a nose extending into the catheter hub interior cavity with adistal end adjacent the membrane; and a needle cannula having a sharpdistal tip, the needle cannula extending distally of the nose throughthe seal member and catheter tube with the sharp distal tip beingexposed distally of the catheter tube, the nose including a recessedbore at the distal end to define an area into which the slit flaps candistend.
 11. The catheter assembly of claim 10, the needle cannula beingaxially slidable through the nose.
 12. The catheter assembly of claim10, the catheter hub having an inner surface between the open proximalend and distal end thereof to define the interior cavity, the membraneof the seal member being normally closed, the seal member including aproximal portion extending proximally from the membrane and sized todefine a nose receiving space, the nose having a proximal portion with across dimension sized to fit snugly against the inner surface adjacentthe proximal opening of the catheter hub and a distal portion sized tofit within the nose receiving space of the seal member.
 13. The catheterassembly of claim 12, the distal portion of the nose having a crossdimension smaller than a cross dimension of the proximal portion of thenose.
 14. The catheter assembly of claim 10, the seal member being aunitary member.
 15. A catheter assembly comprising: a catheter hubhaving an open proximal end and a distal end and an inner surfaceextending therebetween to define an interior cavity, and a catheter tubeextending distally from the catheter hub distal end; a rigid actuatorextending proximally in the interior cavity of the catheter hub from thecatheter hub distal end to a free end; and a seal member disposed in theinterior cavity of the catheter hub, the seal member including amembrane and a distal portion extending distally from the membrane to adistal end with a sealing outlet bore and a proximal portion extendingproximally from the membrane to a proximal opening, the distal portionhaving an actuator cavity therein between the membrane and the sealingoutlet bore, the actuator extending through the sealing outlet bore intothe actuator cavity with the distal end of the seal member being spacedproximal of the distal end of the catheter hub a first distance and theproximal opening of the seal member being spaced distal of a proximalend of the interior cavity a second distance, the membrane beingnormally closed, the seal member being axially shiftable along theactuator a third distance in a distal direction in the interior cavityto force the membrane over the free end of the actuator and open themembrane, the third distance being less than the first distance suchthat the seal member is not axially compressed after being axiallyshifted the third distance to open the membrane.
 16. A catheter assemblycomprising: a catheter hub having an open proximal end and a distal endand an inner surface extending therebetween to define an interiorcavity, and a catheter tube extending distally from the catheter hubdistal end; a rigid actuator extending proximally in the interior cavityof the catheter hub from the catheter hub distal end to a free end; anda seal member disposed in the interior cavity of the catheter hub, theseal member including a membrane and a distal portion extending distallyfrom the membrane to a distal end with a sealing outlet bore and aproximal portion extending proximally from the membrane to a proximalopening, the distal portion having an actuator cavity therein betweenthe membrane and the sealing outlet bore, the actuator extending throughthe sealing outlet bore into the actuator cavity with the distal end ofthe seal member being spaced proximal of the distal end of the catheterhub a first distance and the proximal opening of the seal member beingspaced distal of a proximal end of the interior cavity a seconddistance, the membrane having an axial thickness, the first and seconddistance each being larger than the axial thickness, and the distalportion and proximal portions of the seal member each having arespective length—larger than the axial thickness, the membrane beingnormally closed to seal the actuator cavity, the seal member beingaxially shiftable along the actuator a third distance in a distaldirection in the interior cavity to force the membrane over the free endof the actuator and open the membrane, the third distance being lessthan the first distance such that the seal member is not axiallycompressed after being axially shifted the third distance to open themembrane.